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June 2016 Blog Posts (6)

A broad look at clinical research regulations

Clinical research regulations are directives that are aimed at making clinical research more effective and ethically justifiable. The tool or mechanism by which regulators ensure that clinical research regulations serve their purpose is what is called Good Clinical Practice (GCP).

Regulatory bodies around the world, irrespective of whether they function at national or global levels, formulate respective clinical research regulations that are aimed at ensuring that…

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Added by Adam Fleaming on June 10, 2016 at 3:16am — No Comments

What are the functions of computer system validation process?

Computer system validation process is described as the documented procedure which assures that a computer system performs the exact functions it is intended to reproducibly, consistently and verifiably. The computer system validation process covers every function and milestone of the computer system:

  • Development of the system
  • Operation of the system
  • The system’s maintenance
  • Its retirement
  • Archiving…
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Added by Adam Fleaming on June 7, 2016 at 2:24am — No Comments

Effective Steps for Validation and 21 CFR Part 11 Compliance (CSV)

If one were to define validation; it can be considered the deed of testing an item or system for the level or extent to which it complies with a standard that it has to show compliance with.

In the case of computer systems, validation is a major requirement for these regulatory bodies/practices:

  • The US FDA
  • European Medicines Agency (EMA)
  • Good Manufacturing Practices (GMP)
  • Good Laboratory Practices (GLP)
  • Good Clinical Practices…
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Added by John Robinson on June 6, 2016 at 2:30am — No Comments

The emerging discipline of Hospitals Management Performance Assessments

The emerging discipline of Hospitals Management Performance Assessments

Over the past few years, Hospitals Management Performance Assessments have begun to gain acceptability and credence in healthcare circles. Hospitals Management Performance Assessments came into being as a result of a conscious effort by advanced countries, mainly European, with sufficient backing from the World Health Organization (WHO) to arrive at some sort of metrics…

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Added by Roger Steven on June 2, 2016 at 7:10am — No Comments

Implementation requirements of FDA's Bioresearch Monitoring Program

If there is one common cause for apprehension between the smallest and biggest, and the best known and least known organizations; it has to be an FDA inspection! Any organization that is subject to an FDA inspection has to get absolutely everything of everything about its activities right to a T, to such an extent that it should be sure simply all the time, through all its processes, that an FDA inspection is not going to invite an FDA action such as a 483…

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Added by Adam Fleaming on June 2, 2016 at 3:08am — No Comments

It is important to ensure food safety in hospitals

It is important to ensure food safety in hospitals

Food-Services

Hospitals being what they are – where patients of almost all kinds visit or stay – are very potent sources of infection. Infection can arise from any part of the hospital. They can spread from patients to patients, from caregivers to patients, from patients to caregivers, from patients to support or administrative staff and vice versa, and so on. An often overlooked source of infection and contamination…

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Added by Roger Steven on June 1, 2016 at 7:16am — No Comments

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Understanding the ways of conducting shrink investigations

Shrink investigation is essentially about examining the causes of shrink (loss) in retail businesses. Although retail is one of the fastest growing areas of business, the possibility of shrink is very high in this area. It is also an overlooked area, because of which many shrinks that could otherwise have been prevented, do not get prevented.Controlling losses is as important as making profits. In fact, it even precedes profit making. A shrink investigation is a means to understanding where the…See More
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Best overall personal safety book? 1 Reply

What do you think is  the best all-in-one book out there for optimizing personal safety and the safety of one's family?  Right now I have …Continue

Started by David R Snell. Last reply by David R Snell on Friday.

Fire codes for residential buildings

Hi,Can anybody kindly give me a hint how to find Fire Codes for residential buildings in different cities in the United States?Continue

Started by Darren Asad Apr 14.

What's your favorite motivational/safety quote? 97 Replies

Favorite Motivational Quote: If you want something, you'll find a way - If not, you'll find an excuse.Favorite Safety Quote: Don't learn safety by accident!Continue

Started by Michelle Sears. Last reply by David Collins Mar 30.

OSHA and Machine Guard Door Safety???

We have what we feel is not a unique situation and were wondering if anyone might of run across this challenge and know more about the requirements.  We are building a small machine system that…Continue

Tags: electric, osha, air, door, interlocked

Started by Scott V Mar 24.

OSHA 500 and 510 9 Replies

Hey Guys,How many of you have taken the 510 and 500 OSHA Trainer course? I am thinking about taking these 2 classes and become an OSHA trainer for my company. What are your guys thoughts on the…Continue

Started by Alfred Good. Last reply by Mymic Mar 15.

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